The present invention relates generally to eye examination devices and more specifically to eyelid speculum used to hold a patient""s eyelids open, and to a disposable kit including a speculum for eye examination.
Various devices have been used in the past for the purpose of holding a patient""s eyelid open to allow access to an eyeball for examination, treatment and ocular surgery. Such procedures are performed on human and animal patients of all ages and all sizes regularly. However, tools for such examinations are typically designed for use in adult human eyes.
Examination of infant eyes is very important in a number of situations. For example, examination for retinopathy prematurity (ROP) is an important clinical task for pediatric ophthalmologists, certain general ophthalmologists and retina specialists. Timely ROP examinations are essential in reducing the incidence of blindness in premature infants. ROP examinations are typically initially performed at the crib or incubator in the neonatal intensive care unit (NICU) with additional exams performed in an out-patient clinic or office. The ROP examination involves the use of an indirect ophthalmoscope, an eyelid speculum and a scleral depressor. It has been estimated that 300,000 ROP examinations are performed in NICU""s in the United States every year.
Examination tools known in the art suffer from at least two deficiencies when used for infants. First, they are typically steel instruments which are heavy and not well-sized to an infant""s eye. Not only are these devices cumbersome to use, but also the appearance may be frightening to family or staff attending the infant. Secondly, the devices currently used are relatively expensive; hence, they are intended for multiple uses. Autoclave sterilization is the only adequate method of cleaning the instruments between use. Instrument cleaning methods other than sterilization, such as alcohol swabs and chlorhexidine gluconate, have been shown to be inadequate for eradicating all microorganisms. Without resterilization, a risk of nosocomial eye infection exists. Substantial cost is incurred in having a sufficient number of instruments available and in reprocessing instruments for reuse.
Further, lack of availability of instruments at hospitals is not uncommon and, hence, it is not unusual for ophthalmologists to transport non-sterile instruments from their offices and use them for multiple examinations without benefit of sterilization.
Thus, there is a need for a lightweight speculum and scleral depressor for use in examining infant eyes which are practically and economically single-use devices.
The present invention includes a single-use disposable eyelid speculum and a scleral depressor. The eye speculum and scleral depressor are intended to be presented to the user in sterile packaging and to be disposed of after a single use. This reduces the risk of nosocomial eye infection. Additionally, the eyelid speculum and scleral depressor are constructed of lightweight material which improves performance. The combination of materials used and design results in a speculum that applies a constant, predictable, uniform force to the eyelids, is conveniently sized to accommodate various ages and sizes of patients and has a less onerous appearance.
The eyelid speculum of the invention has an elongated curved arm formed from an elastic, single piece element. The elongated curved arm is curved such that the two ends of the arm are in a generally parallel and opposing position. Integrally formed spoons are formed as a portion of the ends of the elongated curved arm. Each of the spoons has a curvature adapted to the shape of the eyelid.
The eyelid scleral depressor of the invention has an elongated handle portion with at least one end of the handle terminating in stem portion. The stem portion terminates in a tip which is configured for touching an eyeball.
The speculum and scleral depressor may be provided as a kit in either separate or combined packaging in a sterilized condition. The kit is intended to be disposable after a single-use.
A method for examining a patient""s eye using the eyelid speculum and scleral depressor is provided. The method for examining a patient""s eye comprises of the steps of positioning the eyelid speculum proximate to the patient""s eye, engaging each of the upper and lower eyelids of the patient""s eye with each of the spoons of the eyelid speculum, applying the scleral depressor to the surface of the eyeball portion of the patient""s eye and manipulating the eyeball by applying pressure to the sclera of the eyeball.